Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Lennon
ORPIC 250 mg TABLETS ORPIC 500 mg TABLETS ORPIC 750 mg TABLETS SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ORPIC 250 mg TABLETS ORPIC 500 mg TABLETS ORPIC 750 mg TABLETS COMPOSITION: Each tablet contains: ORPIC 250 mg TABLETS: 291 mg ciprofloxacin hydrochloride, equivalent to 250 mg ciprofloxacin ORPIC 500 mg TABLETS: 582 mg ciprofloxacin hydrochloride, equivalent to 500 mg ciprofloxacin ORPIC 750 mg TABLETS: 873 mg ciprofloxacin hydrochloride, equivalent to 750 mg ciprofloxacin PHARMACOLOGICAL CLASSIFICATION: A - 20.1.1 Broad and medium spectrum antibiotics PHARMACOLOGICAL ACTION: Ciprofloxacin is a synthetic 4-quinolone derivative. Ciprofloxacin is bactericidal and acts by inhibiting the A subunit of DNA gyrase (topoisomerase) which is essential in the reproduction of bacterial DNA. Spectrum of activity: (See Indications) Streptococci and enterococci are less susceptible. Enterococcus faecium, Ureaplasma urealyticum, Nocardia asteroides are usually resistant. Most anaerobic bacteria, including Bacteroides fragilis, Clostridium difficile and Treponema pallidum are resistant to ciprofloxacin, although some (eg Peptococcus, Peptostreptococcus) may be moderately sensitive. Pharmacokinetics Ciprofloxacin is absorbed from the gastro-intestinal tract. Oral bioavailability is approximately 70% and a peak plasma concentration is achieved 0,5 to 2 hours after oral dosing. Absorption may be delayed by the presence of food, but is not substantially affected overall. The plasma half-life is about 3,5 to 4,5 hours and there is evidence of moderate accumulation. Half-life may be prolonged in severe renal failure and to some extent in the elderly. Plasma protein binding ranges from 20 to 40%. Ciprofloxacin is widely distributed in the body and tissue penetration is extensive. It appears in the Les hele dokumentet